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Mifepristone and Misoprostol for Fetal Demise (MIMID)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00177372
First received: September 12, 2005
Last updated: January 28, 2016
Last verified: January 2016
  Purpose
This is a pilot clinical trial to evaluate whether the medical management of early pregnancy failure with mifepristone and misoprostol is an effective and acceptable treatment. Subjects with early pregnancy failure receive mifepristone followed 24 hours later by vaginal misoprostol for medical management. Subjects then return on study day 3 for a repeat ultrasound to assess passage of pregnancy tissue. subjects who still have a gestational sac present at Day 3 receive a second dose of vaginal misoprostol. All subjects have a follow-up at Day 15, by phone for those who passed the pregnancy with the first dose of misoprostol, and in person for those who received a second dose. Questionnaires are administered at the beginning and end of the study to determine acceptability.

Condition Intervention Phase
Anembryonic Pregnancy
Gestation Abnormality
Intrauterine Fetal Demise Term
Drug: mifepristone/misoprostol
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Mifepristone and Misoprostol for the Treatment of Early Pregnancy Failure: a Pilot Clinical Trial

Resource links provided by NLM:


Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • to determine if medical management with mifepristone and misoprostol for early pregnancy failure is an effective and acceptable treatment [ Time Frame: 1-2 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • to evaluate if the treatment of early pregnancy failure with mifepristone and misoprostol is as effective as induced abortion with these medications [ Time Frame: 1-2 weeks ] [ Designated as safety issue: No ]
  • to assess if mifepristone/misoprostol treatment is acceptable to patients with early pregnancy failure [ Time Frame: 1-2 weeks ] [ Designated as safety issue: No ]
  • to assess the predictors/indicators for successful mifpristone/misoprostol treatment in patients with early pregnancy failure [ Time Frame: 1-2 weeks ] [ Designated as safety issue: No ]

Enrollment: 30
Study Start Date: January 2005
Study Completion Date: September 2005
Primary Completion Date: September 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Mifepristone 200 mg followed 24 hours later by misoprostol 800 mcg vaginally
Drug: mifepristone/misoprostol
mifepristone 200 mg followed 24 hours later by misoprostol 800 mcg vaginally
Other Name: Mifeprix/Cytotec

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria: healthy hemodynamically stable females with a non-viable pregnancy

Exclusion Criteria:

  • orthostatic hypotension, contraindication to either mifepristone or misoprostol, treatment during current pregnancy to provide surgical or medical evacuation of the uterus, evidence of ovarian hyperstimulation syndrome, known or suspected pelvic infection,known or suspected clotting defect or receiving anticoagulants, cardiovascular disease, current breastfeeding, pregnancy with and IUD in situ, current participation in another clinical trial, prior participation in this trial, suspected or confirmed endometrial AV malformation, clinical indication requiring the karyotyping of products of conception
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00177372

Locations
United States, Pennsylvania
Magee-Womens Hospital
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
University of Pittsburgh
Investigators
Principal Investigator: Mitchell D Creinin, MD Magee-Womens Hospital
  More Information

Publications:
Responsible Party: University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00177372     History of Changes
Other Study ID Numbers: Pittirb0409119 
Study First Received: September 12, 2005
Last Updated: January 28, 2016
Health Authority: United States: Food and Drug Administration
Individual Participant Data  
Plan to Share IPD: No

Additional relevant MeSH terms:
Fetal Death
Stillbirth
Pregnancy Complications
Death
Pathologic Processes
Misoprostol
Mifepristone
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Anti-Ulcer Agents
Gastrointestinal Agents
Oxytocics
Abortifacient Agents, Steroidal
Contraceptives, Oral, Synthetic
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Contraceptives, Postcoital, Synthetic
Contraceptives, Postcoital
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Luteolytic Agents
Menstruation-Inducing Agents

ClinicalTrials.gov processed this record on September 29, 2016